Beta-Blocker Continuation Versus Interruption in Heart Failure Worsening

Phase 4

Completed

• Conditions: Heart Failure, Congestive
• Interventions: Drug: beta-blocker treatment

• Registration Number: NCT00162565
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

The objective of the B-Convinced study is to demonstrate the non-inferiority of beta-blocker continuation compared to its interruption in patients with congestive heart failure who are treated by a beta-blocker and present with an episode of heart failure worsening with pulmonary oedema requiring hospital admission.

162 patients will be randomized in cardiology centers in France. Clinical status (primary endpoint) will be evaluated with a standardized questionnaire 3 days after hospital admission.

Detailed Description

Therapeutic strategy of beta-blocker treatment during an episode of heart failure worsening remains unclear. The objective of the B-Convinced study is to demonstrate that continuation of beta-blocker treatment in case of hospitalisation for heart failure worsening is as safe as the interruption of such treatment.

Hypothesis: The proportion of patients clinically improving within 3 days is not inferior when beta-blocker treatment is maintained compared to beta-blocker interruption in case of hospitalisation for heart failure worsening with pulmonary oedema.

Design: Open, randomized non-inferiority trial on two parallel groups of patients. Randomization performed centrally with a vocal server.

Tested Hypothesis: 90% of success in the interruption group, power of 80%, non-inferiority limit of 15% (relative reduction). 162 patients are required with such a hypothesis.

Primary Endpoint: Clinical improvement within 3 days of hospital admission evaluated by the investigator by a standardized questionnaire.

Secondary Endpoints: Clinical improvement at day 8 or at hospital discharge, morbidity-mortality at 4 months.

34 participating centres in France.

Study Timeline

• Study Start: 2004-11
• Status Verified: 2005-08
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-13
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Last Update Submitted: 2009-05-22
• Last Update Posted: 2009-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

• Patients with heart failure treated with beta-blocker; hospitalisation for heart failure worsening with pulmonary oedema.
• Left ventricular ejection fraction less than 40%

Exclusion Criteria

• Indication of intravenous positive inotropic treatment
• Indication to withdraw beta-blocker treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	beta-blocker treatment	bbloquant treatment

Primary Outcome Measures

Name	Time	Method
Clinical status (questionnaire): the percentage (%) of patients with clinical improvement is the primary endpoint criterion.	at day 3 of hospital admission

Secondary Outcome Measures

Name	Time	Method
Clinical status (evaluation by investigator and autoevaluation by patient)	at day 8 after hospital admission
BNP change	between admission, day 3 and day 8
Mortality, hospital admission, % of patients with beta-blocker treatment	at 3 months

Trial Locations

Locations (32)

Hôpital Victor Dupuy; 🇫🇷 Argenteuil, France

Les Etablissements Hospitaliers du Bessin; 🇫🇷 Bayeux, France

Hôpital Ambroise Paré; 🇫🇷 Boulogne-Billancourt, France

Centre Hospitalier Universitaire de Caen; 🇫🇷 Caen, France

Hôpital Fontenoy de Chartres; 🇫🇷 Chartres, France

Centre Hospitalier de Cholet; 🇫🇷 Cholet, France

Hôpital Antoine Béclère; 🇫🇷 Clamart, France

Hôpital Beaujon; 🇫🇷 Clichy, France

Hôpital de Corbeil; 🇫🇷 Corbeil, France

Hôpital Henri Mondor; 🇫🇷 Créteil, France

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